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Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)

NCT05516498 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2025-08-15

No results posted yet for this study

Summary

This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.

Conditions

Interventions

DRUG

Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet)

placebo capsule (matching zibotentan capsule) placebo tablet (matching dapagliflozin tablet)

DRUG

Part A: zibotentan (dose B) + dapagliflozin

zibotentan capsule dapagliflozin tablet

DRUG

Part B: Placebo (matching zibotentan capsule & matching dapagliflozin tablet)

placebo capsule (matching zibotentan capsule) placebo tablet (matching dapagliflozin tablet)

DRUG

Part B: placebo (matching zibotentan capsule) + dapagliflozin

placebo capsule (matching zibotentan capsule) dapagliflozin tablet

DRUG

Part B: zibotentan (dose A) + dapagliflozin

zibotentan capsule dapagliflozin tablet

DRUG

Part B: zibotentan (dose B) + dapagliflozin

zibotentan capsule dapagliflozin tablet

DRUG

Part B: zibotentan (dose C) + dapagliflozin

zibotentan capsule dapagliflozin tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-05-22
Completion
2025-07-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Netherlands
  • Romania
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516498 on ClinicalTrials.gov